Surgical drains



March 18, 1969 E. L. KETTENBACH 3,433,227

SURGICAL DRAINS Filed Oct. 25, 1965 Sheet March 18, 1969 E. L. KETTENBACH SURGICAL DRAINS Filed Oct. 25, 1965 Sheet INVENTOR. WFPD L. KE77EVBA7C/l,

United States Patent Ofice 3,433,227 Patented Mar. 18, 1969 Claims ABSTRACT OF THE DISCLOSURE A cholecystostomy appliance including an open-ended flexible cylindrical barrel for insertion into an incision in a human gallbladder. The barrel has a pair of radially extending thin flexible fins adjacent the opposite ends thereof to resist the accidental withdrawal of the barrel from the gallbladder. A drainage tube is attached to the end of the barrel external of the gallbladder drainage. A second tube may be provided to introduce a sterile fluid whereby residual stones may be flushed out of the gallbladder through the drainage tube during the postoperative period. The drainage tube may have a large diameter portion intermediate its ends which can be incised for the insertion of a pair of forceps through the barrel into the gallbladder for the removal of stones. A flexible tape may be secured to the barrel to provide a fistulous tract upon the removal of the barrel from the gallbladder.

This invention relates to surgical appliances, and more particularly to drains for cholecystostomies.

The presence of gallstones in a gallbladder causes severe pain and often requires surgery. In fact, gallbladder surgery is one of the most common types of abdominal surgery. The gallbladder stores bile, and when food is ingested, the gallbladder contracts and squeezes the bile down through the cystic duct which is at the outlet of the gallbladder. From the cystic duct, the bile flows through the common bile duct into the duodenum, where the bile mixes with food and aids in the digestion of fats. If stones are present in the gallbladder, a stone may be pushed into the outlet as the gallbladder contracts, thereby causing a temporary obstruction. This obstruction causes pain. The obstruction is usually only temporary, and when the stone falls away from the outlet of the gallbladder, the pain disappears. Quite often, however, a small stone will become impacted in the neck of the cystic duct and cause a complete mechanical obstruction. When this happens, the gallbladder usually becomes acutely inflamed and its wall becomes swollen and thickened. Mucous cells in the lining of the gallbladder are stimulated to secrete large quantities of mucous which distends the gallbladder even further until it becomes palpable below the right rib cage. At this point, surgical intervention is usually required. Without treatment, as the pressure within the gallbladder increases, the blood vessels in its wall are compressed shut. Any tissue deprived of its blood supply becomes gangrenous. Gangrene, perforation, generalized peritonitis, and death are the maximum consequences of failure to treat the acutely obstructed gallbaldder.

When the gallbladder is acutely obstructed, inflamed and swollen, it is technically difiicult and clinically hazardous to attempt to remove the organ. Accordingly, the gallbladder is simply opened and drained. This operation is called a cholecystostomy. In most cases, it is possible to remove all the stones within the gallbladder at the time the gallbladder is opened and drained. Frequently, however, all of the stones within the gallbladder are not removed, either because their presence is undetectable by the surgeon, or they are technically impossible to remove. For example, a stone impacted in the neck of the cystic duct is frequently out of reach of both palpation and instrument removal due to the swelling and distortion of the anatomy in this area. Even the use of X-ray techniques during the operation are unsatisfactory in determining the presence or absence of residual stones. Blood clots, clumps of exudate, and a shaggy necrotic lining of the gallbladder all make the interpretation of X-ray studies under these conditions diflicult. As a result, it is not uncommon for one or more stones to remain in the gallbladder at the conclusion of a cholecystostomy.

The patient who has a residual gallstone in his gallbladder following a cholecystostomy is faced with a second operation for removal of the residual stone. The second operation is much more diflicult and hazardous than the first, because of the rapid development of vascular inflammatory adhesions and the marked distortion of anatomy which occurs after the first operation. Almost a year must elapse before these technical impediments to second surgery have resolved. Rarely can a patient tolerate a cholecystostomy tube for that long a period of time, and once the tube has been removed the patient is a candidate for another attack of acute obstructive cholecystitis. If that should occur, he will be subjected to another drainage procedure, since again it is too hazardous to attempt to remove the gallbladder under those conditions.

The only drainage tubes generally available at the present time for use in a cholecystostomy are the mushroom and Pezzer catheters. Although these tubes do a good job of draining fluid from the gallbladder, there is no tube or surgical appliance presently available which is designed to allow for the removal of residual stones within the gallbladder.

Accordingly, it is an object of this invention to provide an appliance for removing residual stones in a swollen gallbladder.

It is a further object of this invention to provide an improved cholecystostomy drain that may be used to facilitate removal of residual stones by irrigation or by instruments.

Another object of this invention is to provide cholecystostomy drains which may be readily inserted and removed.

These objects are accomplished in accordance with the preferred embodiment of the invention by an appliance in the form of a hollow, semi-rigid barrel attached to a flexible thin drain tube. The barrel is provided with radial fins at opposite ends for retaining the barrel within a gallbladder. In a modified form of the invention, a manifold is mounted on the end of the barrel opposite the drain tube and the manifold has a plurality of openings spaced around the periphery of the barrel. A separate conduit extends from the manifold along the barrel and the drain tube for supplying water to the manifold for irrigation or for applying suction to remove the bile. The end of the drain tube opposite the barrel may be provided with an adapter in which there is a screen for intercepting and collecting stones which might normally flow with the bile through the appliance and down into a bedside collection bottle.

This preferred embodiment is illustrated in the accompanying drawings in which:

FIG. 1 is a side elevational view of a large diameter appliance in accordance with this invention schematically showing the drain inserted in a gallbladder;

FIG. 2 is a cross sectional view of the adapter for the large diameter appliance;

FIG. 3 is a cross sectional view of the barrel portion of the large diameter appliance;

FIG. 4 is an elevational view of the modified form which is a small diameter appliance; and

FIG. 5 is a cross sectional view of the small diameter drian barrel.

Referring to FIG. 1, a typical gallbladder 2 is shown schematically. The gallbladder contains stones 4 and one of the stones is in the cystic duct 6 which connects the gallbladder with the common bile duct 8. Normally, when food is ingested, the gallbladder contracts and forces bile out of the gall-bladder 2, through the cystic duct 6 and into the common bile duct 8. The stone 4 in the duct 6 obstructs the flow of the bile out of the gallbladder 2, and the gallbladder becomes swollen and inflamed. The patients skin 10 is also shown schematically in FIG. 1.

The cholecystostomy drain of this invention may have several forms, a large diameter formof the invention being illustrated in FIGS. 1 to 3, while a small diameter form is illustrated in FIGS. 4 and 5. As shown in FIG. l, the large diameter drain 12 includes a stiff, resilient barrel portion 14 having one end connected to a thin walled, flexible tube 16 by means of an adhesive or other suitable means. The tube 16 preferably has a greater width at its middle portion than at either end. The barrel 14 has a pair of very thin, soft, flexible fins 18 which are each spaced from one end of the barrel 14. Between the end of the barrel 14 and one of the fins 18, a manifold 20 in the form of a hollow annular ring is secured to the barrel. As shown in FIG. 3, the manifold 20 is mounted on the exterior of the barrel 14, but the manifold may also be mounted on the inside of the barrel, so that the outer diameter of the manifold is approximately the same as the diameter of the barrel. The manifold 20 has a plurality of radial holes 2-2 formed in its outer surface. A conduit 24 is secured to the barrel 14 and communicates with the interior of the manifold 20. The conduit 24 is preferably flexible and is fastened to the tube 16, as shown in FIG. 1.

The manifold shown in FIG. 3 is merely illustrative of the types of manifolds that might be employed. For exampled, the tubular barrel 14 may be in the form of two thin walled cylinders arranged coaxially, with a space between them. The water outlet holes would then be provided in the outer cylinder. Water would flow into the space between the cylinders from the conduit 24 and outward radially through the holes in the outer cylinder.

The opposite end of the tube 16 is secured to an adapter 26. The adapter 26 is formed of a rigid material and has a projection 28 for receiving the end of the conduit 24 when it is not in use. The adapter 26 also may have a screen 30 for retaining gallstones that pass into the adapter. The outlet of the adapter 26 may be connected to suitable collecting apparatus.

In utilizing the cholecystostomy appliance, an incision is made in the wall of the gallbladder 2. The short, semirigid barrel 14 is inserted through the incision in the gallbladder 2, with the fins 18 positioned on opposite sides of the wall of the gallbladder. The barrel may be inserted by pinching together the sides of the barrel, and then releasing the barrel when the lower fin 18 is inside the gallbladder. Unless the incision is unusually large, the barrel will fit tightly in the incision when it returns to its normal shape. Therefore, conventional purse-string sutures, or other additional securing means are unnecessary. The fins 18 hold the barrel in its desired position and prevent the barrel from slipping in or out.

Several days after surgery, a cholecystocholangiogram (X-ray) is taken. This is done by injecting an opaque fluid through the cholecystostomy drain tube. The opaque fluid fills the gallbladder, and if the cystic duct is not obstructed, the dye will fill not only the gallbladder, but the cystic duct, common duct, hepatic ducts, biliary radicles in the liver, and some dye will flow through the ampulla of Vader into the duodenum. X-ray pictures are taken during and after the injection. Residual stones, anywhere in the gallbladder or biliary duct system, will stand out as negative shawods within the opaque dye.

If residual stones are demonstrated within the gallbladder, their removal is essential, and is accomplished by injecting sterile water through the conduit 24, after removing the end of the conduit from the projection 28 and connecting the end to any suitable means for supplying sterile water. The water is injected under pressure through the conduit 24 into the manifold 20 and is sprayed outwardly through the holes 22. The patients body is positioned in such a way that the drain 16 extends downwardly from the barrel 14 and as the stream of water flows out of the holes 22, the stones, bile, and other fluids flow into the open end of the barrel 14 under the force of gravity. Stones pass downwardly through the drain 1-6 and are retained on the screen 30 on the adapter 26. The adapter 26 should be made of a transparent plastic so that stones. on the screen 30 can be observed.

If it should be found that the stone cannot be removed by irrigation, an incision 29 should be made through the widest portion of the drain tube 16 one to three inches above skin level. Conventional stone forceps 3-1 may then be inserted through the lumen of the drain tube and through the barrel to permit instrument removal of the stone, as shown in FIG. 1.

The conduit 24 may also be utilized during the postoperative period by connecting it with a suction pump to draw bile from the gallbladder before it reaches the distal end of the discus, and thereby preclude the remote possibility of a leakage of bile between the gallbladder and the barrel 14. The conduit 24 would also be the logical channel through which to inject opaque dye during the postoperative X-ray studies.

A modified form of the invention is illustrated in FIGS. 4 and 5. A gallbladder 32 with a cystic duct '34 and a common bile duct 36 is shown schematically in FIG. 4. The small diameter drain 38 includes a barrel portion 40 and a tubular portion '42. Preferably, both the barrel 40 and the tube 42 are formed of a soft, thin, resilient material which will maintain a lumen. The barrel 40 has a pair of radial fins 44 which are formed of a relatively soft flexible material. The skin 46 is shown schematically in FIG. 4. The barrel 40 is inserted through an incision in the gallbladder 32 by manually collapsing the barrel and inserting it through the incision. When the barrel is released, it springs outwardly. The fins 44 prevent the barrel 40 from being accidentally pulled out of the gallbladder 32.

A flexible tape 48 is secured at one end to the drain 38. The opposite end of the tape is anchored to the serosal surface of the gall bladder with a cat gut suture at the time the drain tube is applied. When the tube 38 is removed after the operation, the thin drain tape 48 will remain in the tract between the gallbladder and the surface of the skin 46 to keep the fistulous tract open until the cholecystotomy wound has healed.

Every and any surgical appliance, and every part thereof which could conceivably be inadvertently left within the human body, must be opaque to X-rays, so that its presence can be detected. This can be accomplished either by impregnation of lead or other opaque substances into the material of which the appliances are made, or by the incorporation of a lead-impregnated thread in the Wall of the appliance. Preferably, the appliances of this invention are constructed of synthetic resin or plastics which may be sterilized at high temperature, without distortion. These appliances are designed to be used once and then thrown away so their design must be simple and the materials of which they are made must be inexpensive.

While this invention has been illustrated and described in several embodiments, it is recognized that variations and changes may be made therein without departing from the invention as set forth in the claims.

I claim:

1. A cholecystostomy appliance comprising a hollow barrel having open opposite ends, a fin on said barrel adjacent said opposite ends, and a tube connected to one end of said barrel, said barrel being formed of a material having sufiicient resiliency in response to radial compression to allow insertion of the other end of said barrel through an incision of substantially the same length as the width of said barrel into a human gallbladder, said fins resisting the accidental withdrawal of said barrel from said incision in the gallbladder, a hollow manifold on said barrel, said manifold having a plurality of openings therein, and a conduit communicating with said manifold, whereby said manifold may be used for irrigation or suction.

2. A cholecystostomy appliance according to claim 1 wherein said tube is flexible and said conduit is resilient.

3. A cholecystostomy appliance according to claim 1 including an adapter secured to said tube at the opposite end thereof, said adapter having a screen mounted therein, whereby gallstones are trapped on said screen.

4. A cholecystostomy appliance comprising a hollow barrel having open opposite ends, a fin on said barrel adjacent said opposite ends, and a tube connected to one end of said barrel, said barrel being formed of a resilient material, an adapter secured to said tube at the opposite end thereof, said tube having a greater width at its mid portion than at its ends, whereby the barrel may be compresed for insertion in a gallbladder and forceps may be inserted through an incision in the tube.

5. A cholecystostomy appliance according to claim 4 wherein said adapter has a screen mounted therein, whereby gallstones are trapped on said screen.

References Cited UNITED STATES PATENTS 1,439,662 12/ 1922 Eppleman et al 12824O 2,491,647 12/1949 Colavita 128-351 X 2,781,759 2/1957 Pawlowski 128-241 2,973,759 3/ 1961 Plymale 128283 3,137,299 6/ 1964 Tabor 128----351 3,162,411 12/1964 Duggan 174-153 3,263,684 8/1966 Bolton 128351 3,330,271 7/1967 'Hozier 128351 X 2,586,940 2/1952 Graham l28349 2,687,731 8/1954 Iarussi et al 128349 FOREIGN PATENTS 214,210 3/1961 Austria.

OTHER REFERENCES A.C.M.I. Catalogue, 1938, p. 22 relied on.

DALTON L. TRULUCK, Primary Examiner.

US. Cl. X.R. 128-241, 276 

